Ondansetron sublingual spray formulation

摘要

The invention is directed to sublingual spray formulations containing ondansetron or a pharmaceutically acceptable salt thereof and water. The invention is further directed to methods for treating or preventing nausea and emesis associated with cancer treatments by administering sublingual spray formulations containing ondansetron or a pharmaceutically acceptable salt thereof to a patient in need thereof.

主权项

1. A sublingual spray formulation comprising:
about 3.9 3% to about 5.2% w/w ondansetron or a salt thereof; about 46.6% to about 75.34% w/w purified water; and about 20.0% to about 48.3% w/w of an excipient selected from the group consisting of propylene glycol, ethanol, cyclodextrin, a binary combination thereof and a tertiary combination thereof,wherein the % w/w is of the total formulation.